Collagenous Colitis
Conditions
Brief summary
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.
Detailed description
This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.
Interventions
DRUGBudesonide
9 mg per day
DRUGMesalazine
3 g per day
DRUGPlacebo
0 g per day
Sponsors
Dr. Falk Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(main): * \> 4 watery/soft stools on at least 4 days in the week prior to baseline * \> 3 stools per day on average within the last 7 days prior to baseline * Symptoms (chronic watery diarrhea) for at least 3 months before baseline * Complete colonoscopy within the last 12 weeks before baseline * Histologically confirmed diagnosis of collagenous colitis
Exclusion criteria
* Evidence of infectious diarrhea * Celiac disease * Endoscopic-histologic findings, which may have caused diarrhea * History of partial colonic resection * Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract * Active colorectal cancer or a history of colorectal cancer * Severe co-morbidity substantially reducing life expectancy * Abnormal hepatic function or liver cirrhosis (ALT, AST or AP \>= 2 x ULN) * Abnormal renal function (Cystatin C \> ULN) * Active peptic ulcer disease, local intestinal infection * Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured * Hemorrhagic diathesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of clinical remission (<= 3 stools per day) after 8 weeks | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to remission | — |
| Impact on stool consistency (watery/soft/solid) | 8 weeks |
| Impact on abdominal pain | 8 weeks |
| Impact on patient's general well-being | 8 weeks |
| Rate of clinical remission (<= 3 stools per day) after 2 weeks | 2 weeks |
| Severity of diarrhea | 8 weeks |
| QoL | 8 weeks |
| PGA | 8 weeks |
| Effect on histopathology | 8 weeks |
Countries
Germany
Outcome results
None listed